510(k) K173825

MC 300R* Nebulizer by Trudell Medical International — Product Code CAF

K173825 is an FDA 510(k) premarket notification submitted by Trudell Medical International for the device "MC 300R* Nebulizer". The FDA issued a decision of Substantially Equivalent on May 2, 2018. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Trudell Medical International has at least 8 other 510(k) clearances on record.